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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

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MENTOR SILICONE BREAST IMPLANTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Fatigue (1849); Anxiety (2328); Depression (2361); Numbness (2415); Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 10/23/2016
Event Type  Injury  
Event Description
Have mentor breast implants.Brain fog, anxiety, depression, numbness, sore, fatigue, loss of ability.
 
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Brand Name
SILICONE BREAST IMPLANTS
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6812690
MDR Text Key83480585
Report NumberMW5071745
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/21/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/23/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age51 YR
Patient Weight50
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